Coronavirus (COVID-19)

COVID-19 (Coronavirus) has drastically impacted all facets of everyday life, including the way in which alcohol sales can be conducted. Though most jurisdictions have banned dine-in customers at restaurants, bars and tap rooms, many have permitted on-premise licensees to temporarily sell to consumers through delivery, curb-side pickup, or off-premise sales. It is imperative to contact

The Food and Drug Administration and the Alcohol and Tobacco Tax and Trade Bureau (TTB) have both recently issued guidance documents to allow for the increased production of alcohol-based hand sanitizer during the COVID-19 outbreak.

The FDA issued two guidance documents to increase the supply of alcohol-based hand sanitizers. The first indicates that FDA will

On March 17, 2020, the U.S. Food and Drug Administration (FDA) issued guidance to food manufacturers and importers in response to the COVID-19 pandemic.  In the guidance, FDA stated it will temporarily not enforce supplier verification onsite audit requirements for receiving facilities and importers under the Food Safety Modernization Act (FSMA) so long as other supplier verification methods are used instead.

Continue Reading FDA Issues Temporary Policy for Food Manufacturers and Importers in Light of COVID-19 Outbreak

Companies directly and indirectly regulated by the U.S. Food and Drug Administration (FDA) face specific challenges separate from other businesses in dealing with the recent outbreak of coronavirus disease 2019 (COVID-19).  At the time of this writing, FDA has not offered specific recommendations on measures that regulated industries should take.  However, good manufacturing practice (“GMP”) requirements and the Federal Food, Drug and Cosmetic Act (“FDCA”) impose obligations on regulated industry to monitor and control employee health and sanitation practices as they relate to product quality and safety.  Beyond the risk of state and federal enforcement, there are reputational risks associated with inadequate management of COVID-19.

Continue Reading Coronavirus in FDA-Regulated Industries